Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET)

Summary

Background

No prospective trial-based data are available for incremental cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in unselected patients, as treated in everyday practice.

Methods

The Basel stent cost-effectiveness trial (BASKET) included 826 consecutive patients treated with angioplasty and stenting for 1281 de-novo lesions, irrespective of indication for angioplasty. Patients were randomised to one of two DES (Cypher, n=264; Taxus, n=281) or to a cobalt-chromium-based BMS (Vision, n=281) and followed up for 6 months for occurrence of major adverse cardiac events and costs. Analysis was by intention-to-treat. The primary endpoint was cost-effectiveness after 6 months, with effectiveness defined as reduction of major adverse cardiac events.

Findings

Cardiac death, myocardial infarction, or target vessel revascularisation occurred in 39 of 544 (7·2%) patients with DES and 34 of 280 (12·1%) with BMS (odds ratio 0·56, 95% CI 0·35–0·91; p=0·02), without significant differences between the two DES. Total costs at 6 months were higher with DES (mean €10 544, SD 6849) than with BMS (€9639, 9067; p<0·0001); higher stent costs of DES were not compensated for by lower follow-up costs. Incremental cost-effectiveness ratio of DES compared with BMS to avoid one major event was €18 311, and costs per quality-adjusted life-year gained were more than €50 000. Subgroup analyses showed that DES were more cost-effective for elderly patients in specific high-risk groups.

Interpretation

In a real-world setting, use of DES in all patients is less cost effective than in studies with selected patients. Use of these stents could be restricted to patients in high-risk groups.

Introduction

The effectiveness of drug-eluting stents (DES) to reduce restenosis compared with bare-metal stents (BMS) has been documented in randomised controlled trials for selected patient groups1, 2, 3, 4, 5, 6 and compared with an historical control in a real-world setting—ie, in everyday clinical practise.⁷ However, DES are markedly more expensive than BMS. If most stents used were DES it would have an effect on many hospital budgets and lead to difficult discussions among physicians and hospital administrators as to which patients should or could be treated with DES. Indications for use of DES targeted at specific lesions or patients were suggested,⁸ but such targeting might be seen as rationing,⁹ particularly by the patient. Since evidence from controlled studies is absent, local solutions vary widely—on the basis of interpretation of available data, budgets, insurance plans, availability of DES, and beliefs. Additionally, third-generation, bare metal cobalt-chromium stents¹⁰ are now available, but no prospective comparisons of DES with these newer BMS have been published so far.

To address these questions—particularly whether the use of DES relative to BMS is good value for money in an everyday setting—the prospective randomised controlled Basel stent cost-effectiveness trial (Basel Stent Kosten Effektivitäts Trial, BASKET) was done. The aim was to compare the 6-month clinical effectiveness of the two available DES with that of a third-generation BMS in relation to the incremental costs in all patients treated with percutaneous coronary intervention (PCI) and stenting. The trial should clarify whether unlimited use of DES in all patients is cost-effective to prevent major adverse cardiac events. The two DES used—the sirolimus-coated Cypher stent (Cordis, Johnson and Johnson, Miami Lakes, Florida, USA) and the paclitaxel-coated Taxus stent (Boston Scientific Corporation, Natick, Massachusetts, USA)—were compared with each other, and each was compared with the cobalt-chromium-based Vision stent (Guidant Corporation, Indianapolis, Indiana, USA). Characteristics of lesions and patients with which DES might be more cost-effective were sought.